Sterilizable, flexible pouches, hereafter referred to as pouches, for maintaining the sterility of objects, such as medical devices, for surgical applications have been utilized for many years. Such pouches typically utilize a bag fabricated from flexible, non-porous plastics such as polyethylene and/or gas-permeable materials such as a DuPont product called Tyvek®. Sterilization is accomplished after sealing the medical device within the pouch by exposing the sealed pouch to, for example, a sterilization gas such as ethylene oxide (EtO) or steam, or radiation such as an electron beam or gamma radiation.
In an example, a pouch may utilize a gas-permeable membrane as a first layer of the pouch. The gas-permeable layer is peelably adhered to a second layer of the pouch. When the medical device stored therein is to be removed, the first layer is separated or peeled from the second layer and the medical device removed.
Sterilizable pouches are generally formed from a continuous strip or strips of materials on an intermittent feed heat sealing machine. An opening to access the pouch is left unsealed such that a medical device may be placed therein. Once the medical device is placed within the pouch, the opening is sealed with a heat sealing machine and the pouch and the medical device are sterilized with a selected sterilization process.
These pouches offer sterile presentation and opening in a small footprint. Additionally, the pouches are low cost, easy to handle, and readily disposable. However, these pouches are not particular durable and may fail during transport, handling, and/or storage. More specifically, a breach, or hole may form in a layer of the pouch, sometimes due to a shipping carton rubbing against the pouch during transport. Alternatively, the medical device stored within the pouch may rub against the layers of the pouch form the inside and cause a breach. Any breach in a layer of the single layer pouch renders the medical device therein unsterile and not suitable for immediate service.
Moreover, the current pouches afford the medical device stored within only minimal protection from damage during transportation, handling and storage. Accordingly, there is a need for sterilizable, flexible medical device pouches with improved durability. There is also a need for sterilizable, flexible medical device pouches that afford better protection to enclosed medical devices.